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Protocol for Phase IIb Study of YM150. A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Sub...

Update Il y a 4 ans
Reference: EUCTR2008-004416-13

Protocol for Phase IIb Study of YM150. A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery. A Phase IIb study to Evaluate the Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects undergoing Elective Hip Replacement Surgery

Woman and Man

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Extract

The primary objective is to evaluate the efficacy and safety of 15 mg bid, 30 mg qd, 30 mg bid and 60 mg qd YM150 and to compare efficacy and safety with enoxaparin 40 mg qd, in subjects undergoing elective hip replacement surgery.

Inclusion criteria

  • Prevention of venous thromboembolism after hip replacement surgery

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